Lyophilization is a commonly used technique for formulation development of small molecules, proteins and vaccines which are unstable in aqueous medium and/or are thermolabile in nature. Lyophilization of drug alone, however, presents certain formulation development challenges, which may be overcome by incorporation of excipients in the formulation. Dextran is often used as excipient during lyophilization as a bulking agent and/or a collapse temperature modifier.
(A. Baheti, L. Kumar, A. Bansal. J. Excipients and Food Chem. 1 (1) 2010, p. 41-54).
Lyophilization techniques are also used in order to improve the dissolution rate and oral bioavailability of drugs with poor solubility and high permeability as well as for Fast Disintegration Tables (FDT) Link
Different fractions of dextran have been used for Lyophilization e.g. Dextran 1, Dextran 10, Dextran 40, Dextran 70 and Dextran 110
MYLOTARG/GEMTUZUMAB
Pfizer (Wyeth)
Chemotherapy (Antibody)
IV
Dextran 40
Link to product
ROTARIX
GSK Biologicals
Lyo oral vaccine vs. Gastroenteritis
Oral
Dextran 1
Link to product
SPASFON LYOC
TEVA (Cephalon)
Oral
Dextran 70
Link to product
ETOPOPHOS
Bristol-Myers Squibb
Chemotheraphy
Dextran 40
Link to product
LIOTHYRONINE
Amdipharm
LiothyronineTreatment of myxoedema coma
Dextran 110
Link to product
Anne-Marie J. Ørkild
Director, International Sales and Business Carbohydrates
Phone: +45 5948 5959
E-mail: dextran@pharmacosmos.com
Pharmacosmos is the only dextran manufacturer holding certificates from the US FDA and European Directorate for the Quality of Medicines (EDQM)
Pharmacosmos delivers a unique dextran quality through a production technology that completely avoids the use of organic solvents and a quality system that meets the strictest cGMP standards for human medicines
Pharmacosmos sells and ships directly to clients everywhere in the World. We deliver Pharmaceutical Quality Dextran of the highest standards, including those of the European Pharmacopoeia (EP), the United States Pharmacopoeia (USP), and the Japanese Pharmacopoeia (JP).